• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIO-RAD LABORATORIES INC LIQUICHEK DIABETES CONTROL LEVEL 1 HEMOGLOBIN CONTROL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIO-RAD LABORATORIES INC LIQUICHEK DIABETES CONTROL LEVEL 1 HEMOGLOBIN CONTROL Back to Search Results
Catalog Number 171
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2018
Event Type  malfunction  
Manufacturer Narrative
The labeling for liquichek diabetes control indicates this product is manufactured from human source material components. The labeling has a warning statement and a caution symbol indicating the product contains human source material and must be treated as potentially infectious. Each human donor unit used to manufacture this product was tested as required by fda accepted methods. Tests results were non-reactive or negative for evidence of infection due to human immunodeficiency virus (hiv), hepatitis b virus (hbv) and hepatitis c virus (hcv). This product may also contain other human source materials for which there are no approved tests. In accordance with good laboratory practice, all human source material should be considered potentially infectious and handled with the same precautions used with patient specimens.
 
Event Description
On september 06, 2018, bio-rad qsd, (b)(4) received a report for a potential adverse event where a laboratory technician splashed liquichek diabetes control lot # 38560 into her eye.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIQUICHEK DIABETES CONTROL LEVEL 1
Type of DeviceHEMOGLOBIN CONTROL
Manufacturer (Section D)
BIO-RAD LABORATORIES INC
9500 jeronimo road
irvine CA 92618 2017
Manufacturer Contact
maria zeballos
9500
jeronimo road
irvine 92618-2017
9495981220
MDR Report Key7906291
MDR Text Key121864315
Report Number2016706-2018-00004
Device Sequence Number1
Product Code GGM
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K052838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number171
Device Lot Number38561
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/25/2018 Patient Sequence Number: 1
-
-